Electrical stimulation of the auditory nerve to assess brain responses
Intraoperative Acute Study to Evaluate Auditory Intranerve Stimulation
This study is testing if a new way of stimulating the auditory nerve during surgery can safely help doctors see how the brain responds in people who are functionally deaf.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hannover Medical School Academic / other |
| Locations | 1 site (Hannover) |
| Trial ID | NCT06306534 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to determine if acute electrical stimulation of the auditory nerve can safely elicit auditory brainstem responses in patients. The study will involve patients undergoing acoustic neuroma removal surgery who are functionally deaf. Participants will receive stimulation through an Auditory Nerve Acute (ANA) Electrode Array to evaluate the feasibility of this approach. The findings could provide insights into the potential for restoring auditory function in individuals with severe hearing loss.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are functionally deaf and scheduled for acoustic neuroma removal surgery.
Not a fit: Patients with additional disabilities that may interfere with the study procedures or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new methods for restoring hearing in patients with severe auditory nerve damage.
How similar studies have performed: While the approach is novel, similar studies exploring electrical stimulation of the auditory nerve have shown promise in preliminary investigations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written informed consent 2. Patients who will undergo an acoustic neuroma removal surgery and are functional deaf 3. Age ≥ 18 years 4. Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists Exclusion Criteria: 1. Disabilities in addition to hearing impairment which might interfere with the study procedure 2. Pregnant and breast feeding woman or other vulnerable population
Where this trial is running
Hannover
- Hannover Medical School — Hannover, Germany (Recruiting)
Study contacts
- Principal investigator: Thomas Lenarz, Prof. Prof. Dr. — Hannover Medical School, Director of otorhinolaryngology
- Study coordinator: Karl-Heinz Dyballa
- Email: dyballa.karl-heinz@mh-hannover.de
- Phone: +4917615328589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.